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Senior Clinical Study Management Specialist
2 months ago
About Us
Abdera Therapeutics Inc. is at the forefront of precision oncology, pioneering next-generation targeted radiation therapies. Our innovative approach leverages a proprietary modular technology platform designed to deliver radioisotopes that selectively target and eliminate tumor cells while preserving healthy tissue. We are dedicated to rapidly developing a diverse array of safe and effective therapies for cancer patients with limited treatment options.
As we expand, we are in search of dedicated professionals who are passionate about innovation and eager to contribute to transformative cancer treatment solutions.
Desired Attributes
We seek inquisitive and dedicated individuals ready to make a significant impact in the field of oncology. Our commitment is to provide new hope to families facing challenging diagnoses. Ideal candidates will collaborate effectively with a diverse team, engaging respectfully while addressing challenges collectively. We are building a dynamic and fast-paced organization focused on discovering and developing the most innovative cancer therapies of tomorrow.
Compensation Range: US$ 120K - 130K
Position Summary
The Senior Study Management Associate (Sr. SMA) will report directly to the Head of Clinical Operations and play a crucial role in overseeing and managing the execution of clinical trials. The Sr. SMA will ensure the quality conduct of trials and data collection by maintaining oversight of CROs and key study CSPs, while also collaborating closely with study sites and investigators. This role requires cross-functional interaction with teams such as Clinical Development, CMC/Supply Chain, Regulatory Affairs, and Project Management.
Key Responsibilities
- Oversee all aspects of clinical trials to ensure timely completion, budget adherence, and compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
- Manage key study parameters including start-up activities, enrollment, site management, and data collection, proactively identifying solutions to challenges.
- Develop and review essential clinical trial documents such as informed consent forms, case report forms, and study manuals.
- Assist in the evaluation, selection, and management of clinical study sites.
- Evaluate and manage CROs and other vendors, including contract and budget negotiations.
- Contribute to project objectives to meet timelines and deliverables.
- Provide regular updates to the cross-functional operations team regarding study progress.
- Analyze and develop action plans to address issues with investigational sites and/or CROs.
- Support the creation of study-specific tools and manuals to ensure data quality and standardization.
- Assist in training new team members on study processes as necessary.
- Track and maintain study metrics and progress, updating the team accordingly.
- Act as the primary contact for study sites.
- Participate in the analysis and reporting of safety issues, patient care concerns, and study design or conduct issues.
- Review and negotiate clinical site study contracts and budgets.
- Plan, coordinate, and present at Investigator Meetings and CRO Training meetings as required.
- Participate in site qualification, initiation, interim monitoring, and close-out visits as needed; conduct sponsor oversight visits to evaluate CRO site monitors.
- Support internal and regulatory audits of clinical trial sites and vendors, assisting with the resolution of audit findings.
Qualifications, Education & Experience
- Bachelor's degree in a scientific discipline or health-related field.
- A minimum of 2 years of experience as a CRA in a biopharmaceutical company or CRO.
- Previous experience with oncology clinical trials is strongly preferred.
- Experience with early development trials is a significant advantage.
- Expertise in radiopharmaceuticals is a definite plus.
Additional Qualifications
- Strong knowledge of FDA regulatory requirements and ICH/GCP guidelines.
- Proven proficiency in implementing, monitoring, and managing clinical trials from start-up to close-out.
- Excellent organizational skills with the ability to prioritize and manage multiple tasks.
- Outstanding verbal and written communication skills.
- Demonstrated problem-solving and negotiation skills.
- Ability to work collaboratively as part of a team.
- Willingness to travel as necessary based on project needs.
- Proficient in Microsoft Office Suite and clinical trial databases (e.g., Medidata Rave, InForm).
Abdera is an equal opportunity employer committed to fostering diversity and inclusion in the workplace. We prohibit any form of harassment or discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
